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Advil Prescribing Information

Package insert / product label
Generic name: ibuprofen
Dosage form: caplets, tablets
Drug class: Nonsteroidal anti-inflammatory drugs

Medically reviewed by Drugs.com. Last updated on Sep 1, 2021.

Active Ingredient

Advil Tablets (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Advil Caplets (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Advil Gel Caplets (in each gel caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

temporarily relieves minor aches and pains due to:
headache
toothache
backache
menstrual cramps
the common cold
muscular aches
minor pain of arthritis
temporarily reduces fever

Warnings

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or non-prescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Heart attack and stroke warning:

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if

stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers or fever reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

under a doctor's care for any serious condition
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
taking any other drug

When using this product

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Advil Tablets

do not take more than directed
the smallest effective dose should be used
adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 tablet, 2 tablets may be used
do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Advil Caplets

do not take more than directed
the smallest effective dose should be used
adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 caplet, 2 caplets may be used
do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Advil Gel Caplets

do not take more than directed
the smallest effective dose should be used
adults and children 12 years and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Other information

read all warnings and directions before use. Keep carton.
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

Advil Tablets

acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Advil Caplets

acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Advil Gel Caplets

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, fractionated coconut oil, gelatin, glycerin, hypromellose, pharmaceutical ink, pregelatinized starch, propyl gallate, purified water, sodium lauryl sulfate, stearic acid, synthetic iron oxides, titanium dioxide, triacetin

Questions or comments?

call toll free 1-800-88-Advil

PRINCIPAL DISPLAY PANEL – 100 Gel Caplet Bottle Carton NDC 0573-0165-40

NDC 0573-0165-40

Advil

Ibuprofen Tablets, 200 mg
Pain Reliever / Fever Reducer (NSAID)

100 Coated Gel Caplets*
*Capsule-Shaped Gelatin-Coated Tablets

Gel
Caplets

000067202 Front Carton

PRINCIPAL DISPLAY PANEL - 300 Tablet Bottle Label - NDC 0573-0154-98

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

300 Coated Tablets

Tablets

PRINCIPAL DISPLAY PANEL - 115 Tablet Bottle Carton - NDC 0573-0151-05

15
FREE
TABLETS

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

115
Coated Tablets

Tablets

PRINCIPAL DISPLAY PANEL - 225 Caplet Bottle Carton - NDC 0573-0161-85

25
FREE
CAPLETS

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

225
Coated Caplets*
*Capsule-Shaped Tablets

Caplets

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton - NDC 0573-0150-20

NDC 0573-0150-20

Advil
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

24 Coated Tablets

Tablets

000067199 Front Carton

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

100 Tablets

Tablets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton - NDC 0573-0160-20

NDC 0573-0160-20

Advil
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

24 Coated Caplets*
*Capsule-Shaped Tablets

Caplets

000067201 Front Carton

Principal Display Panel - 225 Caplet Bottle Label – 0573-1711-14

NDC 0573-1711-14

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

225 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PAA085439 Bottle Label

Advil
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0165
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERRIC OXIDE RED
GELATIN, UNSPECIFIED
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
MEDIUM-CHAIN TRIGLYCERIDES
PROPYL GALLATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
WATER
Product Characteristics
Color BROWN (one side is brown while the other side is yellow) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Advil
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0165-20 1 BOTTLE in 1 CARTON
1 24 TABLET, COATED in 1 BOTTLE
2 NDC:0573-0165-30 1 BOTTLE in 1 CARTON
2 50 TABLET, COATED in 1 BOTTLE
3 NDC:0573-0165-40 1 BOTTLE in 1 CARTON
3 100 TABLET, COATED in 1 BOTTLE
4 NDC:0573-0165-41 1 BOTTLE in 1 CARTON
4 125 TABLET, COATED in 1 BOTTLE
5 NDC:0573-0165-42 1 BOTTLE in 1 CARTON
5 150 TABLET, COATED in 1 BOTTLE
6 NDC:0573-0165-31 1 BOTTLE in 1 CARTON
6 75 TABLET, COATED in 1 BOTTLE
7 NDC:0573-0165-25 1 BOTTLE in 1 CARTON
7 36 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0154
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
METHYLPARABEN
POVIDONE, UNSPECIFIED
PROPYLPARABEN
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
WHITE WAX
DIACETYLATED MONOGLYCERIDES
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code Advil
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0154-35 1 BOTTLE in 1 CARTON
1 150 TABLET, COATED in 1 BOTTLE
2 NDC:0573-0154-75 1 BOTTLE in 1 CARTON
2 200 TABLET, COATED in 1 BOTTLE
3 NDC:0573-0154-17 3000 POUCH in 1 CASE
3 2 TABLET, COATED in 1 POUCH
4 NDC:0573-0154-89 50 POUCH in 1 CASE
4 2 TABLET, COATED in 1 POUCH
5 NDC:0573-0154-84 1 BOTTLE in 1 CARTON
5 225 TABLET, COATED in 1 BOTTLE
6 NDC:0573-0154-98 300 TABLET, COATED in 1 BOTTLE
7 NDC:0573-0154-16 3 POUCH in 1 CARTON
7 2 TABLET, COATED in 1 POUCH
8 NDC:0573-0154-60 360 TABLET, COATED in 1 BOTTLE
9 NDC:0573-0154-59 1 BOTTLE in 1 CARTON
9 200 TABLET, COATED in 1 BOTTLE
10 NDC:0573-0154-21 200 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0151
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
METHYLPARABEN
POVIDONE, UNSPECIFIED
PROPYLPARABEN
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
WHITE WAX
DIACETYLATED MONOGLYCERIDES
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code Advil
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0151-12 10 TABLET, COATED in 1 VIAL
2 NDC:0573-0151-13 3 VIAL in 1 PACKAGE
2 10 TABLET, COATED in 1 VIAL
3 NDC:0573-0151-10 10 VIAL in 1 PACKAGE
3 10 TABLET, COATED in 1 VIAL
4 NDC:0573-0151-21 1 BOTTLE in 1 CARTON
4 36 TABLET, COATED in 1 BOTTLE
5 NDC:0573-0151-20 2 VIAL in 1 PACKAGE
5 10 TABLET, COATED in 1 VIAL
6 NDC:0573-0151-48 2 CARTON in 1 PACKAGE
6 1 BOTTLE in 1 CARTON
6 100 TABLET, COATED in 1 BOTTLE
7 NDC:0573-0151-30 1 BOTTLE in 1 CARTON
7 130 TABLET, COATED in 1 BOTTLE
8 NDC:0573-0151-05 1 BOTTLE in 1 CARTON
8 115 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0161
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
METHYLPARABEN
POVIDONE, UNSPECIFIED
PROPYLPARABEN
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
WHITE WAX
DIACETYLATED MONOGLYCERIDES
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code Advil
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0161-35 1 BOTTLE in 1 CARTON
1 150 TABLET, COATED in 1 BOTTLE
2 NDC:0573-0161-51 1 BOTTLE in 1 CARTON
2 200 TABLET, COATED in 1 BOTTLE
3 NDC:0573-0161-85 1 BOTTLE in 1 CARTON
3 225 TABLET, COATED in 1 BOTTLE
4 NDC:0573-0161-65 65 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0166
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERRIC OXIDE RED
GELATIN, UNSPECIFIED
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
MEDIUM-CHAIN TRIGLYCERIDES
PROPYL GALLATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
WATER
Product Characteristics
Color BROWN (one side is brown while the other side is yellow) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Advil
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0166-51 1 BOTTLE in 1 CARTON
1 200 TABLET, COATED in 1 BOTTLE
2 NDC:0573-0166-85 225 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
METHYLPARABEN
POVIDONE, UNSPECIFIED
PROPYLPARABEN
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
WHITE WAX
DIACETYLATED MONOGLYCERIDES
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code Advil
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0150-20 1 BOTTLE in 1 CARTON
1 24 TABLET, COATED in 1 BOTTLE
2 NDC:0573-0150-30 1 BOTTLE in 1 CARTON
2 50 TABLET, COATED in 1 BOTTLE
3 NDC:0573-0150-40 1 BOTTLE in 1 CARTON
3 100 TABLET, COATED in 1 BOTTLE
4 NDC:0573-0150-31 1 BOTTLE in 1 CARTON
4 75 TABLET, COATED in 1 BOTTLE
5 NDC:0573-0150-32 1 BOTTLE in 1 CARTON
5 60 TABLET, COATED in 1 BOTTLE
6 NDC:0573-0150-41 1 BOTTLE in 1 CARTON
6 125 TABLET, COATED in 1 BOTTLE
7 NDC:0573-0150-42 1 BOTTLE in 1 CARTON
7 150 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
METHYLPARABEN
POVIDONE, UNSPECIFIED
PROPYLPARABEN
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
WHITE WAX
DIACETYLATED MONOGLYCERIDES
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code Advil
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0160-20 1 BOTTLE in 1 CARTON
1 24 TABLET, COATED in 1 BOTTLE
2 NDC:0573-0160-30 1 BOTTLE in 1 CARTON
2 50 TABLET, COATED in 1 BOTTLE
3 NDC:0573-0160-40 1 BOTTLE in 1 CARTON
3 100 TABLET, COATED in 1 BOTTLE
4 NDC:0573-0160-25 1 BOTTLE in 1 CARTON
4 36 TABLET, COATED in 1 BOTTLE
5 NDC:0573-0160-31 1 BOTTLE in 1 CARTON
5 75 TABLET, COATED in 1 BOTTLE
6 NDC:0573-0160-41 1 BOTTLE in 1 CARTON
6 125 TABLET, COATED in 1 BOTTLE
7 NDC:0573-0160-42 1 BOTTLE in 1 CARTON
7 150 TABLET, COATED in 1 BOTTLE
8 NDC:0573-0160-17 1 BOTTLE in 1 CARTON
8 115 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-1711
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
METHYLPARABEN
POVIDONE, UNSPECIFIED
PROPYLPARABEN
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
WHITE WAX
DIACETYLATED MONOGLYCERIDES
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code Advil
Contains
Packaging
# Item Code Package Description
1 NDC:0573-1711-14 1 BOTTLE in 1 CARTON
1 225 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company 829390975 ANALYSIS(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711), LABEL(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711), MANUFACTURE(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711), PACK(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Frequently asked questions

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